US FDA Guidance for Industry Oct – Dec 2024

DateTitle of guidance
and link to document		Type and level
of guidance		About the guidance
1 Oct 2024Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and AnswersFinalThis document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs. The guidance provides recommendations regarding the requirements under 21 CFR part 11 (part 11), pursuant to which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

This guidance expands upon recommendations in the guidance for industry Part 11, Electronic Records; Electronic Signatures — Scope and Application (August 2003) (2003 part 11 guidance) that pertain to clinical investigations conducted under 21 CFR parts 312 and 812. Other related guidances are listed in the Appendix.